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临床试验/NCT02790008
NCT02790008已完成不适用

Magnetic Resonance Imaging and Fibrosis: Histological and Functional Changes in Left Ventricular Function Caused by Aortic Valve Disease

Linkoeping University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Left ventricular function:

研究概览

简要总结

Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy, dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting time for operation and postoperative exercise training is presently unknown.

The investigators aim to (1) determine the changes in LVF for patients on the waiting list; (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to fibrosis and physical capacity.

The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic resonance tomography and myocardial biopsy on the same patients) makes it possible to establish relationship between results of histology and imaging; quantifying and qualifying fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care prior to and after operation.

详细描述

AORTIC VALVE DISEASE & VENTRICULAR FUNCTION Aortic valve disease is the most common valvular heart disease in Europe (46.4%). The valve can be stenotic (aortic stenosis, AS) or can leak (aortic regurgitation, AR). While mostly elderly patients suffer from AS (a steadily growing group due to the increasing population above 60 years), AR occurs in younger individuals (20-60 years in general) who are still working and have a long life expectancy. The current treatment is aortic valve replacement (AVR) and in Sweden approx. 1800 AVR are performed every year with an increasing tendency. AVR is a procedure with low mortality (1.7%) nevertheless there is limited information available about postoperative morbidity, physical performance and quality of life.

Present guidelines suggest surgery when patients are presented with symptoms and/or show impairment of LVF (increasing LV diameters, declining ejection fraction - EF). These are though fairly crude measures as both symptoms and LV dilatation occur late in the natural history of the disease. Furthermore, we found previously that symptoms and LVF did not correlate which warrants the quest for searching more precise indicators.

AS causes pressure and AR causes volume overload which the LV compensates by concentric or eccentric hypertrophy initially. As the disease progresses even histological changes present e.g. diffuse fibrosis. Regional fibrosis after myocardial infarction is known to cause impaired LVF. However, there is no information available in the medical literature on how diffuse myocardial fibrosis affects LVF and whether it would be reversible following prosthetic valve implantation.

Cardiac surgery always carries risks for complications (e.g. mortality, stroke, postoperative arrhythmias, infections etc.) and life with a prosthetic heart valve is not necessarily uncomplicated. Our previous studies showed that preoperative impairment of the LVF can be irreversible and, as Gjertson showed, can progress to heart failure despite operation. Postoperative heart failure has a profound impact on long-term prognosis.

FIBROSIS & CARDIAC MAGNETIC RESONANCE IMAGING (cMRI) Well defined ischemic scars visualized reliably on cMRI by late gadolinium enhancement making it a useful diagnostic modality for myocardial viability in the clinical practice. Currently, in-vivo information on diffuse myocardial fibrosis is limited and optimal imaging method for clinical use is not established yet.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with aortic valve disease

排除标准

  • concomitant cardiac co-morbidity,
  • concomitant surgical intervention,
  • symptomatic lung disease,
  • mental or physical disability limiting participation.

结局指标

主要结局

Left ventricular function:

时间窗: 1 year

a composite measure of ejection fraction = EF (%); left ventricular wall thickness lateralt and septalt (mm), left ventricular volumes (ml)

Degree of fibrosis

时间窗: 1 year

semi-quantitative scale 1-4

次要结局

  • Diastolic Function(1 year)
  • Physical capacity(1 year)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eva Tamas

university lecturer

Linkoeping University

研究点 (1)

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